SWOG clinical trial number
S2205
ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Open
Phase
Accrual
29%
Abbreviated Title
ICE COMPRESS
Status Notes
This study is open to patient accrual effective 3/16/23 at 12 p.m. Pacific Time.
Activated
03/16/2023
Research committees
Symptom Control and Quality of Life
Patient Study Materials
Patient Clinical Trial Summary
Download PDF of Patient Clinical Trial Summary
Eligibility Criteria Expand/Collapse
Participants must have a diagnosis of a solid tumor malignancy. Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
•Weekly paclitaxel for 12 consecutive weeks
•Weekly paclitaxel for 12 consecutive weeks plus carboplatin (weekly for 12 consecutive weeks or every 3 weeks for 4 consecutive cycles)
•Paclitaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery
•Docetaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib); Participants must be >/+= 18 years old; must not have pre-existing clinical peripheral neuropathy from any cause; must not have a history of Raynaud’s phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia; and must not have any open skin wounds or ulcers of the limbs at the time of randomization. Participants must be offered the opportunity to participate in specimen banking, must be able to complete PRO questionnaires in English or Spanish and must agree to complete the PRO questionnaires at all scheduled assessments.
•Weekly paclitaxel for 12 consecutive weeks
•Weekly paclitaxel for 12 consecutive weeks plus carboplatin (weekly for 12 consecutive weeks or every 3 weeks for 4 consecutive cycles)
•Paclitaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery
•Docetaxel plus carboplatin every 3 weeks for 6 consecutive cycles without chemotherapy pause for surgery.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib); Participants must be >/+= 18 years old; must not have pre-existing clinical peripheral neuropathy from any cause; must not have a history of Raynaud’s phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia; and must not have any open skin wounds or ulcers of the limbs at the time of randomization. Participants must be offered the opportunity to participate in specimen banking, must be able to complete PRO questionnaires in English or Spanish and must agree to complete the PRO questionnaires at all scheduled assessments.
Other Clinical Trials
SWOG Clinical Trial Number
S2205
ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Research Committee(s)
Symptom Control and Quality of Life
Activated
03/16/2023
Accrual
29%
Open
Phase
SWOG Clinical Trial Number
S2010
A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone To Improve Persistence with Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN)
Research Committee(s)
Symptom Control and Quality of Life
Activated
01/17/2023
Accrual
80%
Open
Phase
SWOG Clinical Trial Number
EAQ202
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Research Committee(s)
Symptom Control and Quality of Life
Activated
10/28/2021
Open
Phase